- Legend Biotech USA, Inc. (Raritan, NJ)
- …level position with responsibilities for providing quality oversight over the validation and qualification activities for equipment, systems, computer systems, ... assessments, technical studies, and any associated documentation in support of computer systems validation , equipment, utilities, and facility qualification,… more
- Twist BioScience (South San Francisco, CA)
- …Eudralex Annex 11, and internal quality standards. Oversee and execute comprehensive computer system validation (CSV) activities, including IQ, OQ, PQ protocols ... (SCADA, DCS, PLC, HMI) from a software integration perspective.Expertise in computer system validation (CSV) and GxP documentation practices, particularly… more
- BioAgilytix (Durham, NC)
- …visibility into validated data.Maintain Audit-Ready Traceability: Ensure comprehensive data-lineage and validation documentation is always ready for FDA , EMA, or ... Microsoft Power Automate to automate high-frequency, repetitive tasks, such as data validation and QC compliance checks.Establish automated data validation and… more
- Aequor (Hicksville, OH)
- …paperwork for upcoming batches. Sets up and monitors cleaning and filling Validation batches according to protocols. Accepts and controls labels for individual ... cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA , EMEA, ANVISA, HS&E, etc.). Ensures all work is performed in a safe,… more
- Eisai, Inc (Nutley, NJ)
- …SQL, CDISC, and CDASH.Familiarity with Clinical Data Management processes, FDA regulations, SDLC methodologies, systems validation .Strong organizational skills ... of Eisai Clinical Computing Environment Support study migration, program validation , technical documentationManage J-Review set up, J-Review user access management,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …training program for Operations (Manufacturing, Warehouse, Facilities & Engineering, Validation , Technical Support, Supply Chain) that supports daily clinical ... quality systems, or learning management systems.Knowledge of cGMP regulations and FDA /EU guidance related to manufacturing of cell based products as well… more
- Aequor (Cincinnati, OH)
- …Perform routine and non-routine physical and chemical testing of commercial, validation and stability samples in accordance to written methodology Analyze data ... COMPLIANCE AND QUALITY Basic knowledge and understanding of USP, cGMP, and FDA regulations Create and maintain lab record documentation (notebooks and computer… more
- Eisai, Inc (Nutley, NJ)
- …analytical skills and report writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. Ability to ... all applicable worldwide regulations and guidelines (eg US, EU Directives, US FDA , PMDA, ICH). Essential Functions Independently conduct audits Review and oversee… more
- Abbott (Lake Forest, IL)
- …ISO13485, CFR 820, 21 CFR Part 11, HIPAA, Data Privacy, GDPR, NIST cybersecurity Framework, FDA Computer System Validation Guidelines, FDA Computer ... Specialist** **Key Responsibilities also include:** + Effectively assess regulatory and validation requirements for computer systems within organization +… more
- Cordis (Irvine, CA)
- …implement practical business solutions under multiple deadlines. + Participate and provide GxP validation support during FDA Computer Software Validation ... user stories, and test scripts; proficient with SQL for data validation . + Excellent facilitation, communication, and stakeholder-management skills. + Motivated to… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that ... coordinating, working, and communicating with personnel across multiple departments. Performs validation activities related to the implementation of computer … more
- Boehringer Ingelheim (St. Joseph, MO)
- …Specialist, CSVC oversees all aspects of computer system and computer system and computerized equipment validation within BIAH Operations, including ... and procedures, and the approval, authoring and execution of validation deliverables to ensure GxP regulatory compliance. The incumbent... requirements for GxP systems as expressed by the FDA , EU or other regulatory agencies with special focus… more
- PCI Pharma Services (Bedford, NH)
- …Collaborate with departments inside the organization to maintain and improve computer system validation processes to ensure robust, efficient, and ... electronic record and electronic signature assessments. + Generate and execute validation (IQ, OQ, and PQ) documentation for computer /computerized systems… more
- Lilly (Pleasant Prairie, WI)
- …partner with the Site Data Leader and Site Tech@Lilly leadership to implement the computer system validation (CSV) and Data integrity strategies and culture for ... corporate objectives and initiatives. **Key Objectives/Deliverables** + Lead and perform computer system validation projects for manufacturing and laboratory… more
- Abeona (Cleveland, OH)
- Job Description JOB TITLE: Computer System Validation Engineer Department: Validation Reports to: Director of Validation As a Computer System ... laboratory, manufacturing, quality) are validated and maintained in compliance with FDA , EMA, and other global regulatory standards. This role involves close… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …providing validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing, and approving ... You will be responsible for planning, executing, and documenting validation activities to meet FDA and potentially...role, you must have at least a** BS/BA in Computer Science, Engineering, Chemistry, or Life Sciences and 5+… more
- Kedrion Biopharma (Melville, NY)
- …portfolio._ _This is an exciting opportunity to make a real impact by shaping our validation program in alignment with FDA , EU, and GAMP 5 standards._ **_Job ... _Kedrion is looking for a_ **_Validation Specialist - Computer Systems_** _to join our team and play...As a Subject Matter Expert (SME), you will lead validation efforts and support the development, commercialization, and lifecycle… more
- Catalent Pharma Solutions (Harmans, MD)
- …Global cGMPs relevant to 21 CFR Part 11 compliance requirements and Global Computer System Validation , USP Guidelines, ICH Guidelines, and ISPE GAMP guidelines. ... **Associate Director, Validation & Engineering** Catalent Pharma Solutions is looking...of life-enhancing and life-saving treatments for patients annually. Our FDA -licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is… more
- Catalent Pharma Solutions (Harmans, MD)
- **Lead Specialist, QA Validation & Engineering** Catalent Pharma Solutions is looking to hire a **Lead Specialist, QA Validation & Engineering** to support our ... of life-enhancing and life-saving treatments for patients annually. Our FDA -licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located… more
- Abbott (Columbus, OH)
- …and implementation of the CAPA management system + Develop, execute and review FDA validation protocols and related documentation in accordance with procedures ... meet Division standards. **WHAT YOU'LL DO** + As a Validation Engineer, you'll have the chance to create and...current Good Manufacturing Practices (cGMP). Familiarity with GAMP5 and FDA 's Computer Software Assurance initiatives are preferred.… more
